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CTRI Number  CTRI/2021/11/037706 [Registered on: 01/11/2021] Trial Registered Prospectively
Last Modified On: 21/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   To study if there is improvement in personal growth and changes in severity of traumatic symptoms after providing therapy using narrative and exposure therapy techniques for adolescents who have been rescued from human trafficking 
Scientific Title of Study   The Efficacy of Narrative Exposure Therapy among Adolescent Female Survivors of Human Trafficking: A Comparative Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sheeba Shamsudeen 
Designation  Ph.D Scholar 
Affiliation  Central Institute of Psychiatry Kanke Ranchi 
Address  Department of Clinical Psychology, Central Institute of Psychiatry, Ranchi
Central Institute of Psychiatry, Kanke Ranchi
Ranchi
JHARKHAND
834006
India 
Phone  9886230271  
Fax    
Email  sheeba.dr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preeti Gupta 
Designation  Assistant Professor of Clinical Psychology 
Affiliation  Central Institute of Psychiatry Kanke Ranchi 
Address  Department of Clinical Psychology, Central Institute of Psychiatry, Ranchi
Central Institute of Psychiatry, Kanke, Ranchi
Ranchi
JHARKHAND
834006
India 
Phone  8709396119  
Fax    
Email  preetiguptacp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Kumar Munda 
Designation  Associate Professor of Psychiatry 
Affiliation  Central Institute of Psychiatry Kanke Ranchi 
Address  Department of Psychiatry, Central Institute of Psychiatry, Ranchi
Central Institute of Psychiatry, Kanke, Ranchi
Ranchi
JHARKHAND
834006
India 
Phone  8797641082  
Fax    
Email  drsanjaymunda@gmail.com  
 
Source of Monetary or Material Support  
CIP Ranchi 
 
Primary Sponsor  
Name  Central Institute of Psychiatry Ranchi 
Address  Central Institute of Psychiatry, Kanke, Ranchi 834006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preeti Gupta  Central Institute of Psychiatry  Department of Clinical Psychology, New Teaching Block, Central Institute of Psychiatry, Kanke, Ranchi
Ranchi
JHARKHAND 		 8709396119

preetiguptacp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee Central Institute of Psychiatry Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F43||Reaction to severe stress, and adjustment disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Narrative Exposure Therapy  14 tri-weekly sessions of 45 to 60 minutes duration each 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  18.00 Year(s)
Gender  Female 
Details  1. Female adolescents in the age group of 13 to less than 18 years old.
2. Adolescent survivors who have been rescued from human trafficking and are presently residing in observation/shelter homes.
3. Adolescent survivors who meet the criteria of screening on the Trafficking Victim Identification Tool.
4. Adolescent survivors with a score ¬>22 on the Kessler Psychological Distress Scale.
5. Adolescent survivors who respond positively to at least 1 traumatic event as per the Life Events Checklist.
6. Adolescent survivors who score between 11 to 50 on the Children’s Global Assessment Scale (CGAS).
7. Consent from a guardian/caseworker/agency staff and assent for the study from the adolescent survivor.
8. Adolescent survivors who can comprehend Hindi and/or English language. 
 
ExclusionCriteria 
Details  1. Adolescent survivors with active substance dependence and severe mental illness as per M.I.N.I KID Screen, except trauma related disorders.
2. History of past psychiatric disorder previous to trafficking or those with a history of chronic or other significant general medical/neurological/organic illness.
3. Adolescent survivors who have intellectual disability or deficits (IQ percentile < 25) on Standard Progressive Matrices.
4. Adolescent survivors with a history of having received any past intervention of psychotherapeutic treatment, except a basic intake counselling session. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Trauma Symptom Severity, Psychological Distress, Global Level of Functioning   pre-test (at baseline), mid-phase test (3rd week), and post-test (6th week) 
 
Secondary Outcome  
Outcome  TimePoints 
Post Traumatic Growth, Resilience, Psychological Well Being  pre-test (at baseline), mid-phase test (at 3rd week), and post-test (at 6th week) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2022 
Date of Study Completion (India) 01/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sheeba.dr@gmail.com].

  6. For how long will this data be available start date provided 21-04-2024 and end date provided 21-04-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The aim of the research is to study the efficacy of Narrative Exposure Therapy on trauma symptomatology, psychological distress, post-traumatic growth, resilience, psychological well-being, and global functioning among adolescent female survivors of human trafficking. Narrative Exposure Therapy for traumatized children and adolescents (KIDNET) is a treatment for survivors who continue to suffer from past experiences of traumatic stressors and is specifically designed for those who have been exposed to complex and multiple traumata, after having survived severe and repeated physical and social threats to life and integrity. Adolescent female survivors of human trafficking between the age group of 13 to less than 18 years who have been rescued from trafficking shall be contacted through the Child Welfare Centre under the Department of Women, Child Development & Social Security, Govt. of Jharkhand after seeking necessary permissions. Informed consent and assent shall be provided to the shelters and the individuals. 30 (20 + 10) individuals who fit the inclusion and exclusion criteria shall be given Narrative Exposure Therapy. 20 individuals shall be given the therapy immediately upon recruitment while 10 individuals shall be taken as a waitlisted control group and will be given treatment after a waiting period of 5 weeks. Inclusion criteria will include Individuals in the age group of 13 to less than years old, female gender, Individuals who have been rescued from human trafficking and are residing in the rescue shelters. Individuals who meet the criteria of screening, those with a history of trauma, those who score above cutoff on Psychological Distress, those with no history of having received any past intervention of psychotherapeutic treatment, except a basic intake counselling session, those abstinent from substances and those who can comprehend Hindi and/or English language. The primary purpose of the research is to assess the presence of trauma symptomatology among adolescent female survivors of human trafficking receiving narrative exposure therapy. The research shall also assess the changes in trauma symptomatology, psychological distress, post-traumatic growth, resilience, psychological well-being and global level of functioning at pre-intervention, mid-intervention, and immediate post-intervention assessment measures among adolescent female survivors of human trafficking receiving narrative exposure therapy. The methodology follows null hypothesis for all the variables under study.   
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